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510(k) K192939

Volumetric Specimen Imager by Clarix Imaging — Product Code MWP

K192939 is an FDA 510(k) premarket notification submitted by Clarix Imaging for the device "Volumetric Specimen Imager". The FDA issued a decision of Substantially Equivalent on December 27, 2019. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2019
Date Received
October 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, X-Ray System
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) (April 24, 2023)
  • K213691 — Solas OR (December 22, 2021)
  • K210955 — Kubtec Mozart Supra (XPERT 84) Radiography System (September 20, 2021)
  • K210957 — Kubec Xpert 80 Radiography System (August 31, 2021)
  • K210956 — Kubtec Mozart (XPERT42) (August 31, 2021)
  • K202713 — TrueView 100 Pro (November 18, 2020)
  • K200756 — Kubtec Mozart Supra (June 12, 2020)
  • K193317 — CoreLite X-Ray Specimen Cabinet (December 13, 2019)
  • K183624 — Kubtec Mozart (Xpert42) (June 20, 2019)

FDA data resources